An interventional study of Thread-embedding acupuncture and Sham Thread-embedding acupuncture in Low Back Pain, sponsored by Indonesia University. Completed at 1 site in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Indonesia University · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn whether thread-embedding acupuncture (TEA) is more effective than sham thread-embedding acupuncture in treating adults with chronic low back pain. The study will also evaluate the safety of TEA.
The main questions it aims to answer are:
Researchers will compare TEA with sham TEA (a procedure that mimics acupuncture without needle insertion or thread placement) to determine whether TEA provides greater and longer-lasting benefits for chronic low back pain.
Participants will:
Outcome Definitions
- Bothersome pain episodes: The number of days in the past 7 days during which the subject experienced bothersome low back pain.
Bothersome low back pain is defined as pain that is sufficiently significant to interfere with daily activities, rest, concentration, or overall comfort. Mild pain or pain that does not interfere with activities is not counted.
- Frequency of routine analgesic use: The number of days in the past 7 days during which the subject consumed routine analgesic medication (taken as prescribed by a physician).
Routine analgesics may include primary analgesics (paracetamol and/or opioids) and/or adjuvant analgesics (muscle relaxants, antiepileptics, antidepressants, antispasmodics).
- Frequency of additional (rescue) analgesic use: The number of days in the past 7 days during which the subject consumed additional (as-needed) analgesic medication when pain remained bothersome.
Additional analgesics may include primary analgesics (paracetamol and/or opioids) and/or adjuvant analgesics (muscle relaxants, antiepileptics, antidepressants, antispasmodics).
2,818 studies on the registry are indexed under Low Back Pain; 482 are open to participants now.
This study's enrollment of 32 is below the median of 60 across 2,268 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
Thread-embedding acupuncture and analgesic therapy
Device: Thread-embedding acupuncture
Sham thread-embedding acupuncture and analgesic therapy
Device: Sham Thread-embedding acupuncture
Thread-embedding acupuncture is performed bilaterally at a pair of lumbar EX-B2 points using needles containing polydioxanone (PDO) threads, positioned 12.5 mm lateral to the spinous processes. The targeted EX-B2 level is selected from L1 to L5 based on the subject's main pain location, informed by dermatome and myotome mapping and lumbar segmental concepts.
Sham thread-embedding acupuncture is performed bilaterally at the lumbar EX-B2 points using needles that are placed in contact with the skin at the acupuncture point sites without skin penetration. The targeted EX-B2 level is selected from L1 to L5 based on the subject's predominant pain location, guided by dermatome and myotome mapping and the principles of lumbar segmental innervation.
Pain Intensity
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS). NPRS is an 11-point numeric scale ranging from 0 to 10, where 0 = no pain and 10 = the worst pain imaginable. Higher scores indicate greater pain intensity.
Time frame: Before therapy, week 2, week 4, week 6, week 8
Health-Related Quality of Life
Health-related quality of life will be assessed using the European Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire, a standardized and validated instrument. The EQ-5D-5L evaluates five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five levels of severity. EQ-5D-5L Index Value: The index score is derived from the five dimensions and typically ranges from less than 0 (health states worse than death) to 1.0 (full health), with higher scores indicating better health-related quality of life.
Time frame: Before therapy (baseline), week 4, and week 8.
Frequency of Bothersome Pain Episodes
The number of days in the past 7 days during which the subject experienced bothersome low back pain. Bothersome low back pain is defined as pain that is sufficiently significant to interfere with daily activities, rest, concentration, or overall comfort. Mild pain or pain that does not interfere with activities is not counted.
Time frame: Before therapy, week 2, week 4, week 6, week 8
Frequency of Routine Analgesic Use
The number of days in the past 7 days during which the subject consumed routine analgesic medication (taken as prescribed by a physician). Routine analgesics may include primary analgesics (paracetamol and/or opioids) and/or adjuvant analgesics (muscle relaxants, antiepileptics, antidepressants, antispasmodics).
Time frame: Before therapy, week 2, week 4, week 6, week 8
Frequency of Additional (extra) Analgesic Use
The number of days in the past 7 days during which the subject consumed additional (as-needed) analgesic medication when pain remained bothersome. Additional analgesics may include primary analgesics (paracetamol and/or opioids) and/or adjuvant analgesics (muscle relaxants, antiepileptics, antidepressants, antispasmodics).
Time frame: Before therapy, week 2, week 4, week 6, week 8
Plan to share: No
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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Indonesia University